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A Randomized Controlled Trial of Innovative Postpartum Care Model for Mother-Baby Dyads.

ABSTRACT: OBJECTIVE:To evaluate the efficacy, safety, and maternal satisfaction of a newly established integrative postpartum community-based clinic providing comprehensive support for mothers during the first month after discharge from the hospital. Our primary interests were breastfeeding rates, readmission and patient satisfaction. METHODS:A randomized controlled trial was conducted in Ottawa, Canada, where 472 mothers were randomized via a 1:2 ratio to either receive standard of care (n = 157) or to attend the postpartum breastfeeding clinic (n = 315). Outcome data were captured through questionnaires completed by the participants at 2, 4, 12 and 24 weeks postpartum. Unadjusted and adjusted logistic regression models were conducted to determine the effect of the intervention on exclusive breastfeeding at 12 weeks (primary outcome). Secondary outcomes included breastfeeding rate at 2, 4 and 24 weeks, breastfeeding self-efficacy scale, readmission rate, and satisfaction score. RESULTS:More mothers in the intervention group (n = 195, 66.1%) were exclusively breastfeeding at 12 weeks compared to mothers in the control group (n = 81, 60.5%), however no statistically significant difference was observed (OR = 1.28; 95% CI:0.84-1.95)). The rate of emergency room visits at 2 weeks for the intervention group was 11.4% compared to the standard of care group (15.2%) (OR = 0.69; 95% CI: 0.39-1.23). The intervention group was significantly more satisfied with the overall care they received for breastfeeding compared to the control group (OR = 1.96; 95% CI: 3.50-6.88)). CONCLUSION:This new model of care did not significantly increase exclusive breastfeeding at 12 weeks. However, there were clinically meaningful improvements in the rate of postnatal problems and satisfaction that support this new service delivery model for postpartum care. A community-based multidisciplinary postpartum clinic is feasible to implement and can provide appropriate and highly satisfactory care to mother-baby dyads. This model of care may be more beneficial in a population that is not already predisposed to breastfeed. TRIAL REGISTRATION:ClinicalTrials.gov NCT02043119.

SUBMITTER: Laliberte C

PROVIDER: S-EPMC4752489 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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A Randomized Controlled Trial of Innovative Postpartum Care Model for Mother-Baby Dyads.

Laliberté Corinne C Dunn Sandra S Pound Catherine C Sourial Nadia N Yasseen Abdool S AS Millar David D Rennicks White Ruth R Walker Mark M Lacaze-Masmonteil Thierry T

PloS one 20160212 2

<h4>Objective</h4>To evaluate the efficacy, safety, and maternal satisfaction of a newly established integrative postpartum community-based clinic providing comprehensive support for mothers during the first month after discharge from the hospital. Our primary interests were breastfeeding rates, readmission and patient satisfaction.<h4>Methods</h4>A randomized controlled trial was conducted in Ottawa, Canada, where 472 mothers were randomized via a 1:2 ratio to either receive standard of care (n ...[more]

PMID: 26871448

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Project description:Background/objectiveParents shape children's early experiences with food, influencing what is served, children's food choices, and how much children eat. Responsive parenting (RP) interventions such as INSIGHT have improved maternal infant feeding practices, but have only been tested among predominantly White families. This secondary analysis of data from the Sleep SAAF (Strong African American Families) RCT tests the effects of an RP intervention designed to prevent rapid infant weight gain on African American mothers' infant feeding practices.MethodsPrimiparous African American mother-infant dyads (n = 194) were randomized to an RP or safety control intervention delivered by community research associates at infant age 3 and 8 weeks. At 16 weeks, mothers completed the Babies Need Feeding questionnaire, the Infant Feeding Styles Questionnaire, and the Babies Need Soothing questionnaire. Logistic regression and general linear models examined the effect of study group on infant feeding practices. Moderation analyses explored whether effects varied by feeding mode (any breast milk versus exclusive formula), maternal age (≥ 20 years versus < 20 years), and maternal pre-pregnancy BMI (with obesity versus not).ResultsRP mothers reported more responsive feeding (p = 0.005, partial η2 = 0.02), lower likelihood of using beverages other than breast milk/formula to soothe their infant (p = 0.01, OR = 0.42, 95% CI [0.2-0.8]), and less pressure with cereal than control mothers (p = 0.09, partial η2 = 0.02). RP mothers also reported less pressure to finish/soothe than controls (p = 0.007, partial η2 = 0.04); feeding mode (B = 0.74, p = 0.003) and maternal age (B = 0.53, p = 0.04) moderated this effect. There were no significant group differences in bottle-feeding practices (e.g., adding cereal to bottle, using an appropriate nipple/bottle size), or in context-based or emotion-based food to soothe.ConclusionsResponsive parenting education influenced some feeding practices of African American mothers. Mothers reported using less pressure, a control-based feeding practice, and more responsive feeding than controls.Trial registrationSleep SAAF: A Strong African American Families Study. www.Clinicaltrialsgov NCT03505203. Registered 3 April 2018.

Project description:BackgroundPostpartum women with overweight/obesity and a history of adverse pregnancy outcomes are at elevated risk for cardiometabolic disease. Postpartum weight loss and lifestyle changes can decrease these risks, yet traditional face-to-face interventions often fail. We adapted the Diabetes Prevention Program into a theory-based mobile health (mHealth) program called Fit After Baby (FAB) and tested FAB in a randomized controlled trial.MethodsThe FAB program provided 12 weeks of daily evidence-based content, facilitated tracking of weight, diet, and activity, and included weekly coaching and gamification with points and rewards. We randomized women at 6 weeks postpartum 2:1 to FAB or to the publicly available Text4baby (T4B) app (active control). We measured weight and administered behavioral questionnaires at 6 weeks, and 6 and 12 months postpartum, and collected app user data.Results81 eligible women participated (77% White, 2% Asian, 15% Black, with 23% Hispanic), mean baseline BMI 32±5 kg/m2 and age 31±5 years. FAB participants logged into the app a median of 51/84 (IQR 25,71) days, wore activity trackers 66/84 (IQR 43,84) days, logged weight 17 times (IQR 11,24), and did coach check-ins 5.5/12 (IQR 4,9) weeks. The COVID-19 pandemic interrupted data collection for the primary 12-month endpoint, and impacted diet, physical activity, and body weight for many participants. At 12 months postpartum women in the FAB group lost 2.8 kg [95% CI -4.2,-1.4] from baseline compared to a loss of 1.8 kg [95% CI -3.8,+0.3] in the T4B group (p = 0.42 for the difference between groups). In 60 women who reached 12 months postpartum before the onset of the COVID-19 pandemic, women randomized to FAB lost 4.3 kg [95% CI -6.0,-2.6] compared to loss in the control group of 1.3 kg [95% CI -3.7,+1.1] (p = 0.0451 for the difference between groups).ConclusionsThere were no significant differences between groups for postpartum weight loss for the entire study population. Among those unaffected by the COVID pandemic, women randomized to the FAB program lost significantly more weight than those randomized to the T4B program. The mHealth FAB program demonstrated a substantial level of engagement. Given the scalability and potential public health impact of the FAB program, the efficacy for decreasing cardiometabolic risk by increasing postpartum weight loss should be tested in a larger trial.

Project description:ObjectiveWith a period prevalence of 21.9% in the year after birth, depression is a common complication of childbearing. We assessed the impact of telephone-delivered depression care management (DCM) on symptom levels, health service utilization, and functional status 3, 6, and 12 months postpartum.MethodsThe randomized controlled trial was conducted at the University of Pittsburgh, Pittsburgh, Pennsylvania, from March 2006 through September 2010. Women (N = 628) who screened positive for depression (a score of 10 or greater on the Edinburgh Postnatal Depression Scale) 4 to 6 weeks postpartum were evaluated with the Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Patient Edition With Psychotic Screen and enrolled in a randomized trial of DCM compared to enhanced usual care (EUC). Clinicians conducted telephone contacts to educate, assist with treatment decisions, monitor symptoms, facilitate access to services, and encourage links to community resources. Independent evaluators collected symptom scores, functional status, and health services use at 3, 6, and 12 months postpartum. Primary outcome was reduction of symptoms as measured by the Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement.ResultsMean depressive symptom and function scores significantly improved (by greater than 50%) in both groups of women but did not differ by DCM versus EUC assignment. Health services use was similar in women randomly assigned to DCM compared to EUC. Women with childhood sexual abuse responded significantly more favorably to DCM on depression and functional measures (all P values < .02).ConclusionsBoth DCM and EUC favorably impacted depression symptom levels and function. The subgroup of women with childhood sexual abuse benefited significantly more from DCM compared to the EUC condition. Regular telephone availability of a clinician is a resource that appears to be particularly therapeutic to women with childhood sexual abuse.Trial registrationClinicalTrials.gov identifier: NCT00282776.

Project description:BackgroundThe study examined the effects of Happy Mother-Healthy Baby (HMHB), a cognitive-behavioural therapy (CBT) intervention on breastfeeding outcomes for Pakistani women with prenatal anxiety.MethodsBreastfeeding practices were evaluated in a randomized controlled trial between 2019 and 2022 in a public hospital in Pakistan. The intervention group was randomized to receive six HMHB sessions targeted towards prenatal anxiety (with breastfeeding discussed in the final session), while both groups also received enhanced usual care. Breastfeeding was defined in four categories: early breastfeeding, exclusive early breastfeeding, recent breastfeeding, and exclusive recent breastfeeding. Early breastfeeding referred to the first 24 h after birth and recent breastfeeding referred to the last 24 h before an assessment at six-weeks postpartum. Potential confounders included were mother's age, baseline depression and anxiety levels, stress, social support, if the first pregnancy (or not) and history of stillbirth or miscarriage as well as child's gestational age, gender. Both intent-to-treat and per-protocol analyses were examined. Stratified analyses were also used to compare intervention efficacy for those with mild vs severe anxiety.ResultsOut of the 1307 eligible women invited to participate, 107 declined to participate and 480 were lost to follow-up, resulting in 720 women who completed the postpartum assessment. Both intervention and control arms were similar on demographic characteristics (e.g. sex, age, income, family structure). In the primary intent-to-treat analysis, there was a marginal impact of the intervention on early breastfeeding (OR 1.38, 95% CI: 0.99-1.92; 75.4% (N = 273) vs. 69.0% (N = 247)) and a non-significant association with other breastfeeding outcomes (OR1.42, 95% CI: 0.89-2.27; (47) 12.9% vs. (34) 9.5%, exclusive early breastfeeding; OR 1.48, 95% CI: 0.94-2.35; 90% (N = 327) vs. 86% (N = 309), recent breastfeeding; OR1.01, 95% CI: 0.76-1.35; 49% (N = 178) vs 49% (N = 175) exclusive recent breastfeeding). Among those who completed the intervention's six core sessions, the intervention increased the odds of early breastfeeding (OR1.69, 95% CI:1.12-2.54; 79% (N = 154) vs. 69% (N = 247)) and recent breastfeeding (OR 2.05, 95% CI:1.10-3.81; 93% (N = 181) vs. 86% (N = 309)). For women with mild anxiety at enrolment, the intervention increased the odds of recent breastfeeding (OR 2.41, 95% CI:1.17-5.00; 92% (N = 137) vs. 83% (N = 123).ConclusionsThe study highlights the potential of CBT-based interventions like HMHB to enhance breastfeeding among women with mild perinatal anxiety, contingent upon full participation in the intervention.Trial registrationClinicalTrials.gov NCT03880032.

Project description:BACKGROUND:Current guidelines for the management of obesity in women planning pregnancy suggest lifestyle modification before conception. However, there is little evidence that lifestyle modification alters pregnancy outcomes. Bariatric surgery results in significant weight loss. This appears to reduce the risk of adverse pregnancy outcomes for the mother but may increase the risk of adverse outcomes for the infant. In order to reduce the risks of obesity-related adverse pregnancy outcomes for both mother and offspring, alternative approaches to the management of obesity in women planning pregnancy are needed. METHODS/DESIGN:This study, a two-arm, parallel group, randomized control trial, will be conducted at the Metabolic Disorders Centre, University of Melbourne. This trial will recruit 164 women aged 18-38 years with a body mass index of 30-55 kg/m2 who plan to conceive in the next 6-12 months. Women will be randomized to one of two 12-week interventions (Group A and Group B). Group A will aim for modest weight loss (MWL; ??3% body weight) using a hypocaloric diet. Group B will aim for substantial weight loss (SWL; 10-15% body weight) using a modified very low energy diet (VLED) program. All participants will be asked to comply with National Health and Medical Research Council (NHMRC) guidelines for exercise and will be provided with standard pre-pregnancy advice according to Royal Australian and New Zealand College of Obstetrics and Gynaecology guidelines. All participants will then be observed for the subsequent 12 months. If pregnancy occurs within the 12-month follow-up period, data on weight and metabolic status of the mother, and pregnancy outcomes of mother and offspring will be recorded. The primary outcome is maternal fasting plasma glucose at 26-28 weeks' gestation, given that this is known to correlate with pregnancy outcomes. Time to conception, live birth rate, gestational weight gain, and a composite of adverse pregnancy outcomes for mother and baby will comprise the secondary outcomes. DISCUSSION:There is increasing emphasis on obese women losing weight before conception. To date, no randomized controlled trial has demonstrated an effective means of weight loss that results in improved pregnancy outcomes for both mother and baby. This study intends to determine if substantial pre-conception weight loss, achieved using a VLED, improves pregnancy outcomes for mother and baby when compared with standard care. This research will potentially change clinical care of an obese woman planning pregnancy. TRIAL REGISTRATION:ANZCTR, 12,614,001,160,628 . Registered on 5 November 2014.

Project description:BackgroundWomen experience changes both physically and psychologically during their transition to motherhood. The postnatal period is a critical time for women to develop maternal self-efficacy. Mobile health interventions may offer a way to reach women during this critical period to offer support and information. Essential Coaching for Every Mother is a text message program that seeks to educate and support women during the first 6 weeks postpartum.ObjectiveThe primary effectiveness objective is to compare the effectiveness of the Essential Coaching for Every Mother program on maternal psychosocial outcomes (self-efficacy, social support, postpartum depression, and postpartum anxiety) immediately after the intervention and 6 months postpartum, collectively as well as stratified by parity. The primary implementation objective is to evaluate the implementation extent and quality of the Essential Coaching for Every Mother program.MethodsThis will be a hybrid type 1 effectiveness-implementation randomized controlled trial. A total of 140 mothers-to-be or new mothers from Nova Scotia will be recruited and randomized to the intervention or control arm, stratified by parity. The intervention arm will receive the Essential Coaching for Every Mother program, which consists of 53 messages sent twice a day for the first 2 weeks and daily for weeks 3 through 6. The control group will receive usual care. Messages are personalized based on the infant's age and the woman's self-selected preference for breastfeeding or formula feeding and tailored with the infant's name and gender. Women can enroll in the program if they are ≥37 weeks pregnant or within 10 days postpartum, with the first message designed to be sent on the second evening after birth. The actual number of messages received will vary based on the timing of enrollment and the infant's date of birth. Participants will complete questionnaires assessing self-efficacy, social support, and postpartum depression and anxiety at baseline (enrollment after birth) and 6 weeks (postintervention) and 6 months postpartum. Implementation data will be collected throughout the trial, and evaluation feedback will be collected at 6 weeks from women who received the intervention.ResultsRecruitment for this study started on January 5, 2021, and is currently ongoing, with an anticipated date of recruitment completion of January 2022.ConclusionsThis study will assess the effectiveness of a postpartum text message program to improve maternal self-efficacy and social support while decreasing postpartum depression and anxiety. It will also shed light on the implementation effectiveness of the program.Trial registrationClinicalTrials.gov NCT04730570; https://clinicaltrials.gov/ct2/show/NCT04730570.International registered report identifier (irrid)DERR1-10.2196/27138.

Project description:Background"Essential Coaching for Every Mother" is a Canadian text message-based program that sends daily messages to mothers for 6 weeks after they give birth. There is a need to explore the program's effectiveness in terms of the participants' experience to guide refinement and modification.ObjectiveThis study aimed to describe the process evaluation of the Essential Coaching for Every Mother randomized controlled trial through an evaluation of the research implementation extent and quality.MethodsParticipants were recruited from Nova Scotia, Canada, between January 5 and August 1, 2021. Enrolled participants were randomized into the intervention or control group. Participants randomized to the intervention group received standard care along with the Essential Coaching for Every Mother program's text messages related to newborn and maternal care for the first 6 weeks after giving birth, while the control group received standard care. Usage data were collected from the SMS text message program used, and participants completed web-based questionnaires at 6 weeks after birth. Quantitative data and qualitative responses to open-ended questions were used to triangulate findings. Quantitative data were summarized using means, SDs, and percentages, as appropriate, while qualitative data were analyzed using thematic analysis.ResultsOf the 295 unique initial contacts, 150 mothers were eligible and completed the baseline survey to be enrolled in the study (intervention, n=78; control, n=72). Of those randomized into the intervention group, 75 (96%) completed the 6-week follow-up survey to provide feedback on the program. In total, 48 (62%) intervention participants received all messages as designed in the Essential Coaching for Every Mother program, with participants who enrolled late missing on average 4.7 (range 1-12) messages. Intervention participants reported an 89% satisfaction rate with the program, and 100% of participants would recommend the program to other new mothers. Participants liked how the program made them feel, the format, appropriate timing of messages, and content while disliking the frequency of messages and gaps in content. Participants also provided suggestions for future improvement.ConclusionsOur process evaluation has provided a comprehensive understanding of interest in the program as well as identified preference for program components. The findings of this study will be used to update future iterations of the Essential Coaching for Every Mother program.Trial registrationClincalTrials.gov NCT04730570; https://clinicaltrials.gov/ct2/show/NCT04730570.

Dataset Information

A Randomized Controlled Trial of Innovative Postpartum Care Model for Mother-Baby Dyads.

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A Randomized Controlled Trial of Innovative Postpartum Care Model for Mother-Baby Dyads.

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